Medtronic DDBC3D1 Patient Manual

Implantable Cardioverter Defibrillator

Patient Manual

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

Innovating for life.

The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries: CareLink, Medtronic, Medtronic CareAlert, Medtronic CareLink. All other trademarks are the property of their respective owners.

How to contact Medtronic

Contact us by phone

Our experienced Patient Services group is available to answer any questions or concerns you may have about your heart device. To speak directly with a Patient Services Specialist, call 1-800-551-5544. Our staff is available Monday through Friday from 8:00 AM to 5:00 PM (Central Standard Time).

Contact us online

Medtronic is dedicated to providing you with the most up-to-date information available about your Medtronic heart device. Website information is available 24 hours a day.

• Medtronic website: www.medtronic.com

• Patient Services website: www.medtronic.com/rhythms

If you would like to submit questions, suggestions, or requests to us online, you can use the online form provided at www.medtronic.com/corporate/contact.jsp.

Contact us by mail or fax

Medtronic, Inc. Patient Services Department Mail Stop MVS 14 8200 Coral Sea Street NE Mounds View, MN 55112

Fax: 763-367-5809

Contacting Medtronic about your ID Card

To update information on your ID card or if you have questions about your ID card, see “Your heart device ID card” on page 89.

Information about you and your device

Your personal information

Your name Your doctor’s name Specialty Your doctor’s name Doctor’s phone Your medications

Emergency contact information

Name/address/phone Name/address/phone

Your heart device information

Type of heart device Lead 1 model number Serial # Lead 2 model number Serial # Lead 3 model number Serial # Date of i mpl ant H osp ital whe re i mpla nte d

Specialty

Serial #

Contents

How to contact Medtronic 3

Chapter 1 Why read this manual? 13

Frequently asked questions 14

Chapter 2 Living life with your heart device 25

Food and medications 26 Recommendations about your physical activity 26

Recreation and activities 27 Driving a car 27

What you need to know about electromagnetic compatibility (EMC) 28

General guidelines for avoiding interference from electrical items or magnets 32

Examples of items that have low or no risk of interfering with your device 42

Precautions about medical procedures 44

Medical procedures that are not recommended 45 Medical procedures that require some precautions 46 Acceptable medical procedures 48

Chapter 3 Your heart has a natural rhythm 51

The anatomy of the heart 51 Electrical conduction in the heart 55 How abnormal heart rhythms affect the heart 58

Tachyarrhythmia – When the heart beats too fast 59 Bradycardia – When the heart beats too slowly 62

Chapter 4 About your heart device 65

What is an ICD? 66

Your heart device 66 Leads 67

What does my heart device do? 70 What types of therapies does my heart device provide? 70

Therapies for a fast or uneven heart rhythm 71

Therapy for a slow heart rhythm 73 What do the therapies feel like? 74 What is Medtronic CareAlert monitoring? 75

Conditions that Medtronic CareAlert monitoring can

detect 76

Checking your Medtronic CareAlert status 77

Chapter 5 Your implant procedure and recovery 79

The implant procedure 80

Making the incision and inserting the leads 80

Testing the leads 81

Implanting the heart device and closing the incision 81 Potential risks after the implant procedure 82 Recovering after your implant surgery 83 Follow-up appointments 85

Chapter 6 Registering your heart device 87

Heart device registration form 88 Your heart device ID card 89

Carry your heart device ID card with you at all times 89 To request a new heart device ID card or update your

personal information 90 If you change your doctor 90

Medtronic heart device travel card 90

Chapter 7 Follow-up care 93

Follow-up information 94

Remote monitoring with the Medtronic CareLink Service 95

Medtronic CareLink Programmer 98

Reviewing information saved by your heart device 99 When to call your doctor or nurse 100 Heart device replacement 101

Chapter 8 Caring for yourself 103

Dealing with anxiety and getting the support you need 104 Medical care 107

Planning for an emergency 108 What your family and friends should know 109

Medtronic Warranty 111

Glossary 113

Index 127

Why read this manual?

Your doctor or doctors should be your first source of information about your heart condition and your general health.

If you have questions about your heart device that are not covered in this manual, contact Medtronic Patient Services (see “How to contact Medtronic” on page 3).

To view or download English and Spanish patient manuals, see www.medtronic.com or contact Medtronic Patient Services.

This manual is for people who are about to have or already have an implantable cardioverter defibrillator (ICD). This manual explains what the heart device is, how it is implanted, what it feels like when you receive therapy from the heart device, and what you can expect after you have your heart device. It’s a good idea to encourage your family and caregivers to review this manual. For your convenience, words that appear in bold are defined in the glossary starting on page 113.

Frequently asked questions

New patients often have the same initial concerns about their heart devices. Here are some of the questions new patients frequently ask.

Why do I need this heart device?

An ICD is designed to relieve heart disease symptoms for most patients. Although this heart device does not prevent or cure your underlying heart rhythm condition, it should improve your quality of life and help you get back to doing things that you haven’t been able to do for a while.

Heart medications and surgical procedures may be prescribed instead of, or in addition to, an ICD. Based on your individual health condition, your doctor has determined that the treatment provided by a heart device may help to improve your symptoms.

Although your heart device is not a cure, it does help to protect you from heart rhythms that can weaken or even endanger your health. Many patients say that this heart device gives them and their families a sense of security. See “Caring for yourself” on page 103 for guidance on dealing with anxiety and other concerns.

14 Why read this manual?

Will I be able to drive?

Whether you will be able to drive or not depends on your individual heart condition. The concern about driving is that you might faint if your heart starts to beat dangerously fast. Many people with a heart device are able to resume driving if their doctor approves and if allowed by the laws and insurance regulations in their state. For more information, see “Driving a car” on page 27. If you have concerns, talk with your doctor.

Will I be able to travel?

Most people who have a heart device can travel without taking special precautions if they follow their doctor’s instructions.

Wherever you travel, your heart device will monitor your heart and provide therapy whenever it is needed. You can travel knowing that resources for your device are available in 120 countries (see the back cover of this manual for information on contacting Medtronic headquarters located worldwide). When you travel, your doctor may also be able to check your heart device remotely with the Medtronic CareLink Service (see page 98 for more information).

Chapter 1 15

It is unlikely that your heart device will trigger the security gates at airports or other secure buildings. If it does, present your heart device ID card. If a handheld screening wand is used, ask the security operator not to hold it over your heart device and not to wave the wand back and forth over your heart device. See “Security systems” on page 41 for more information.

A multilanguage heart device travel card is available that provides instructions in several languages for safe security scanning; the card is especially useful for international travel. See page 90 for more information about the multilanguage heart device travel card.

If you have any other travel-related questions, contact Medtronic Patient Services (see page 3) or consult the Medtronic travel website at www.medtronic.com/traveling.

Can I walk through antitheft systems found in public places?

Yes, simply walk through the antitheft system at a normal pace. Under some circumstances, the systems located in stores, libraries, and other places may temporarily interfere with your heart device if you stop or

16 Why read this manual?

linger near this equipment. The interference stops when you move away from the equipment.

Can I use a mobile phone?

Yes, you can use mobile phones (including cellular phones and other wireless phones). However, mobile phones may cause electrical interference with your heart device when the phone is turned on and held too close to your heart device. Any effect is temporary, and simply moving the phone away will return the heart device to its previous state of operation.

To avoid any possible interference between mobile phones and your heart device, keep all mobile phones at least 6 inches (15 centimeters) away from your heart device. When using a mobile phone, hold it to the ear that is farthest away from your heart device. Also, do not carry a mobile phone close to your heart device, such as in a shirt pocket (or in a pants pocket if your heart device is implanted in your abdomen). For more information about using mobile phones and other wireless communication devices, see page 32.

Chapter 1 17

Can I use a microwave oven and other electrical items?

Yes, you can use a microwave oven as well as major appliances, electric blankets, and heating pads. See “Living life with your heart device” on page 25 for information about electrical items and any restrictions or cautions you should know about.

Will my heart device need to be replaced?

Yes. Because your heart device operates using a battery sealed inside the heart device, the entire heart device will need to be replaced when battery power falls to a low level. Battery power is affected by many factors, including how often your heart device provides therapy to your heart. The battery for your type of heart device typically lasts 4 to 7 years after it is implanted.

The battery power is checked at each heart device follow-up appointment. Your doctor or nurse will let you know when you need to have your heart device replaced.

18 Why read this manual?

How often will my doctor need to check my heart device?

When you go home after your implant surgery, your doctor will periodically check your heart device. These follow-up appointments can be performed at your clinic, or if your clinic subscribes to the Medtronic CareLink Service, you can send your heart device information directly to your doctor or clinic from home. For more information about follow-up services, see “Follow-up care” on page 93.

How do I know if my heart device battery is still working?

The strength of your heart device battery is checked during your follow-up appointments, either in the clinic or through built-in device monitoring. Medtronic CareAlert monitoring is a safety feature built into your heart device that can be set up by your doctor to alert you with a beeping sound when the heart device battery power is getting low. For more information about the Medtronic CareAlert monitoring feature, see “What is Medtronic CareAlert monitoring?” on page 75. Because the battery is sealed inside your heart device and cannot be recharged, your heart device will need to be replaced when the battery power is low. For

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more information about heart device replacement, see “What is Medtronic CareAlert monitoring?” on page 75.

What if my heart device is making a beeping sound?

Your heart device may make a beeping sound if the Medtronic CareAlert monitoring feature is turned on. Your doctor can have your heart device alert you with a beeping sound under certain conditions, such as the following conditions:

• The number of therapies you have received has increased.

• The battery power of your heart device is low.

If one of these conditions is detected by your heart device, it will make a beeping sound for up to 30 seconds, at least once a day. The alerts will continue until your heart device is checked by your doctor or nurse. Do not be alarmed by the beeping. This alert feature is designed to get your attention. If you hear beeping tones from your heart device, call your doctor for instructions. For more information about the Medtronic CareAlert monitoring feature, see “What is Medtronic CareAlert monitoring?” on page 75.

20 Why read this manual?

Will my device deliver a therapy shock during normal activity?

This can happen, but it is unlikely. Your heart device is designed to respond to abnormal heart rates and rhythm patterns. Normal exercise or physical activity shouldn’t trigger your heart device to deliver a therapy shock.

If this ever happens, stop the activity and notify your doctor. Your doctor may change the settings of your heart device to prevent this from happening.

Can others feel a therapy shock if they are touching me?

Though it is very unlikely, if you receive a therapy shock, anyone touching you may feel the shock as a muscle spasm or tingle. This can be startling, but it will not hurt the person.

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What if I receive a therapy shock?

Ask your doctor or nurse what you should do if your heart device delivers a therapy shock. Your doctor or nurse should provide you with specific instructions about when you should contact your doctor if you have received a therapy shock.

In general, follow these steps if you feel the symptoms of a rapid heart rhythm or if you receive a therapy shock:

1. Stay calm and move to where you can lie down or sit comfortably.

2. Have someone stay with you until you feel better. If you receive more than one therapy shock or if you remain

unconscious for more than 1 minute, have a companion call 911 for an ambulance.

If you remain unconscious and you have no pulse, a companion trained in cardiopulmonary resuscitation (CPR) should begin CPR immediately. When your heart starts beating again, your companion should stop CPR.

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Note: Anyone touching you during a therapy shock might feel your muscles contract slightly; they also might see you jump with a sudden start. A therapy shock will not harm a person touching you.

3. If you do not feel well after the shock, have someone call your doctor and take you to the hospital emergency room.

4. Follow your doctor’s or nurse’s directions about when to call your doctor after receiving a shock. You may be asked the following questions:

– What were you doing right before the shock?

– What symptoms did you notice before the shock?

– How did you feel right after the shock?

– How are you feeling right now?

Can I have sexual relations?

People often have questions about resuming sexual relations after receiving a heart device. Most people resume sexual activity, based on their doctor’s guidance. You and your partner should be able to enjoy all the benefits of intimacy.

Chapter 1 23

Any kind of physical activity is not likely to cause your heart device to deliver a shock. But if it does happen during intercourse, stop and notify your doctor just as you would if it happened during exercise. Your partner will not be hurt by the shock. They may feel a tingle or slight muscle spasm, but nothing more.

24 Why read this manual?

Living life with your heart device

Many people resume their normal daily activities after full recovery from surgery (see “Your implant procedure and recovery” on page 79). However, there may be certain situations that your doctor will ask you to avoid. Your doctor will provide the most important guidance for your particular condition.

This chapter has important information about the following topics:

• Food and medications (see page 26).

• Your physical activity now that you have a heart device (see page 26).

• Information and instructions about any electrical equipment that may cause interference with your heart device (see page 28).

• Precautions about certain types of medical procedures (see page 44).

Food and medications

Your doctor may instruct you to eat or avoid eating certain foods. For information about food, talk with your doctor.

Your doctor may prescribe medications that will treat your heart condition. Please talk with your doctor about medications.

Recommendations about your physical activity

Upon the advice of your doctor, you can gradually return to your normal lifestyle and to activities such as these:

• Pursuing hobbies or recreational activities

• Returning to your job

• Resuming strenuous activity

• Resuming sexual activity

•Traveling

Your doctor might ask you to avoid situations where a few seconds of unconsciousness could be dangerous to you or others. Such situations might include driving, swimming or boating alone, or climbing a ladder.

26 Living life with your heart device

Recreation and activities

Avoid rough physical contact that could cause you to fall or to hit your implant site. Your heart device can be damaged or your leads could become detached from the heart device during rough contact.

• If you use a rifle or shotgun, rest the butt on the shoulder of the side opposite from your heart device.

• In activities that use a shoulder harness, protect your heart device and leads from jolts or rough rubbing.

• If you plan to scuba dive, discuss your medical condition with your doctor. General recommendations about scuba diving vary depending on many factors. Ask your doctor to contact Medtronic Technical Services for the most up-to-date information about scuba diving recommendations.

If you have additional questions about any recreational activities you normally pursue, contact Medtronic Patient Services (see page 3).

Driving a car

Discuss with your doctor whether you can safely drive a car or other vehicle. You may be able to resume driving, depending on local laws

Chapter 2 27

and insurance regulations and on your medical condition. Your doctor will decide what is best for your safety and the safety of others.

Seat belts are a very important safety device and should always be worn while driving or riding in a vehicle. While you are driving or riding in a vehicle, the shoulder seat belt strap may feel uncomfortable during the first few weeks after surgery. You can place a soft towel between the seat belt strap and your implant site to cushion the area.

What you need to know about electromagnetic compatibility (EMC)

Everything that uses electricity produces an electromagnetic energy field. This energy field surrounds the electrical item while it is

connected to a source of electricity (even a battery source). The energy field is strongest near the item and weakens with distance from the item.

The relationship between these energy fields and your heart device is called electromagnetic compatibility (EMC). Most electromagnetic energy fields are small and weak and do not affect your heart device. Electrical items that generate strong electromagnetic energy fields may not be compatible with your heart device.

28 Living life with your heart device

Because your heart device is designed to sense the electrical activity of your heart, it is possible that it may sense a strong electromagnetic energy field outside your body and deliver a therapy that is not needed or withhold a therapy that is needed.

Several safeguards are built into your heart device to shield it from strong electromagnetic energy fields. For example, the metal case of your heart device acts as a shield against electromagnetic energy fields. There are also electronic filters built into your heart device that help your heart device distinguish between external electromagnetic energy fields and the internal electrical pulses of your natural heartbeat.

You can avoid potential EMC problems by keeping your heart device a minimum distance away from the electrical item. See the following pages for more information, including the recommended safe distances for certain types of electrical items.

How could electromagnetic energy fields affect my heart device?

High electromagnetic energy fields could affect how your heart device senses your heart rhythm. Because your heart device is designed to

Chapter 2 29

sense the electrical activity of your heart, it may also sense a strong electromagnetic energy field outside your body.

If your heart device is exposed to a strong electromagnetic energy field, it may not detect an abnormal heart rhythm or it may deliver a therapy shock when your heart does not need it. Any effects of electromagnetic energy fields on your heart device are temporary and will stop when you move away from the source of the electromagnetic energy field.

What do I do if I think that an electrical item is affecting my heart device?

If you feel dizzy, feel rapid or irregular heartbeats, or receive a shock while using an electrical item, release whatever you are touching or move away from the item. Your heart device should immediately return to its normal operation. If you receive a therapy shock or if your symptoms do not improve when you move away from the item, consult with your doctor or contact Medtronic Patient Services (see page 3).

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